Merck & Co. Inc. affirmed its stance regarding alternative dosing regimens for GARDASIL®9, the Human Papillomavirus 9-valent Vaccine, highlighting the need for more data before considering changes to the current dosing recommendations. The FDA requires evidence showing that a single-dose regimen is as effective as the approved three-dose regimen and ensures no decrease in efficacy for HPV disease endpoints beyond cervical persistent infection. Additionally, there is currently no data supporting the efficacy of single-dose regimens in men. Until sufficient data is available, Merck believes that the CDC's recommendations should align with the approved two- and three-dose regimens, which have been extensively evaluated and have a proven public health impact.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.